Homeopathic Ear Drops for Otitis Media Study

Overview

The purpose of this study is to determine if a commercially available homeopathic ear drop preparation is effective in reducing symptoms in children 6 months – 11 years old with acute otitis media in whom the health care provider has recommended that antibiotics not be immediately administered. A total of 150 study patients with otitis media will be randomized to receive homeopathic ear drops, or no ear drops, in addition to receiving standard care. It is postulated that children using the ear drops will have more rapid resolution of symptoms and need fewer antibiotics than those randomized to not receive the ear drops.

Full Title of Study: “Homeopathic Ear Drops for Children With Otitis Media Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2013

Interventions

  • Drug: Hyland’s earache drops
    • 3-4 drops in affected ear 3 times a day as needed for up to 5 days

Arms, Groups and Cohorts

  • Experimental: Homeopathic ear drops
    • Commercially available homeopathic ear drops
  • No Intervention: standard therapy
    • standard therapy for otitis media, no ear drops

Clinical Trial Outcome Measures

Primary Measures

  • Severity of Symptoms of Otitis Media
    • Time Frame: 15 days
    • Ear Treatment Group – 5 scores. Parent rated severity of otitis media symptoms including fever, earache, irritability, feeding and sleeping. Each symptom rated 0, 4 or 7. Total scores range 0 (least symptoms) to 35 most symptom. ETG-5 scores collected 12-15 days after enrollment
  • Administration of Antibiotics
    • Time Frame: 15 days
    • Number of participants who filled antibiotic prescription (or called back for promised antibiotic prescription) after being diagnosed with acute otitis media at index visit.

Secondary Measures

  • Side Effects From Study Remedy
    • Time Frame: 15 days
    • Any “other symptoms” reported by parents in logbooks. Logbooks were returned by 72/105 participants randomized to the homeopathic ear drops group and 78 of those randomized to standard therapy alone.

Participating in This Clinical Trial

Inclusion Criteria

  • Age 6 months – 11 years old – Diagnosed with otitis media by clinician at participating clinic – Clinician determines that a "watch and wait" antibiotic prescription treatment plan is optimal management Exclusion Criteria:

  • Antibiotic treatment during past 7 days – Homeopathic treatment within past 30 days – History of serious chronic illness (e.g. diabetes, autoimmune disease, cystic fibrosis – Perforated tympanic membrane – Immediate antibiotic treatment plan decided by examining clinician

Gender Eligibility: All

Minimum Age: 6 Months

Maximum Age: 11 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Washington
  • Provider of Information About this Clinical Study
    • Principal Investigator: James Taylor, Professor – University of Washington
  • Overall Official(s)
    • James A Taylor, MD, Principal Investigator, University of Washington

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